ISO 13485 – Quality Management System for Medical Devices

Are you a manufacturer of medical devices? Do you market medical devices under your own label? If the answer is yes, then it is mandatory to meet relevant medical legislation and regulatory requirements.

The requirements of the standard, amongst others, encompass customer details, legislation, design and development, labelling and packaging, product identification and traceability.

Benefits of ISO 13485 certification:

– As a manufacturer, you meet the legal requirements of the European directive 98/79/EC
– Have the trust of your customers, end-users and patients
– Easier access to market
– Awareness and vigilance amongst your employees
– As Original Equipment Manufacturer (OEM) and/or an Own Brand Labeller (OBL) you meet all the necessary requirements of manufacturers of medical devices
– Maintain a continual process of improvement regarding processes and products
– Ability to participate in tenders issued by medical aid societies
– High quality standards for production
– Identification of risks

If CE Notification is required or desirable, implementing ISO 13485 provides a solid foundation for this process.

The new version of this standard was published in March 2016 and companies had until 1 March 2019 to adapt their systems to meet the new requirements.

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